Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-20 @ 4:44 PM
Study NCT ID:
NCT03539393
Status:
AVAILABLE
Last Update Posted:
2025-07-23
First Post:
2018-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fremanezumab Compassionate Use Program for Pediatric Patients
Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Organization:
Study Overview
Official Title:
Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine
Status:
AVAILABLE
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Compassionate Use Program (CUP) based on a licensed physician's unsolicited request. Specifically, this CUP is for male and female pediatric patients 6 to 17 years with a diagnosis of either episodic or chronic migraine who have successfully completed the Teva sponsored study TV48125-CNS-30084 (SPACE study).
Detailed Description:
Patients must have successfully completed the clinical trial according to the 30084 protocol, without any major protocol violations or tolerability issues, or who are anticipated to complete this trial within the next 2months, and whose Requesting/Treating Physician is requesting continued supply of the investigational medicinal product (IMP) known as TEV-48125 (fremanezumab) on behalf of the patient.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TV48125-MH-80011 | OTHER | Sponsor | View |